An Attempt to Find Out Root Cause of a Pain Producing Knee Disease

NCT ID: NCT04496440

Last Updated: 2023-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-23

Study Completion Date

2018-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was focused on a type of arthritis (knee) in which patients develop pain with disabilities in sitting and walking etc. In advance stage the person is bereft of his/her personal physical activities. The prevalent treatment is temporary and dis-satisfactory. A new treatment was designed and a trial was conducted on 125 patients (100 in the trial group, 25 in the control group) for a duration of six months.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study was focused on establishing the cause and treatment of a painful knee joint disease (Primary Osteoarthritis Knee = OA Knee). At present the cause and treatment are not known. The study was based on a hypothesis, designing a treatment and testing it through a clinical trial. This established that the deficient full flexion or deficient full extension of knee joints, producing contracture in their capsules was the cause and the correction (Contracture Correction Therapy = CCT) was the cure of the disease. The correction was carried out by passive flexion or passive extension of affected knee through eight body postures designed specifically during the study.

To test the efficacy a multi-centre, multi surgeon six months study on 125 patients was carried out, patients were divided into Trial and Control groups. The effects were measured by primary outcome measure - The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score and other measure EuroQol-Visual Analogue Scales (EQ-VAS) score, DFF\*, DFE\^ at 0, 6 ,12 and 24 weeks.

The "Intervention" for 1st group was CCT and for the 2nd group was "No intervention".

\* Deficient full flexion

\^ Deficient full extension

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis Arthroplasty Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Trial Group

Contracture correction therapy

Contracture Correction Therapy

Intervention Type OTHER

Non-drug and non-surgical treatment of contracted knee capsules

Control Group

No new intervention, patients continued with the previous treatment.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Contracture Correction Therapy

Non-drug and non-surgical treatment of contracted knee capsules

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age =\>30 years
* Knee pain which appeared without any apparent cause, exacerbated by exertion and subsided by rest.
* Presence of limited morning stiffness
* No history of infection, inflammation or trauma to rule out secondary OA
* Disability in sitting, climbing stairs or walking

Exclusion Criteria

* Backache
* Leg pain (e.g. sciatica)
* Inability to lie supine (e.g. kyphosis)
* Inability to lie prone (e.g. central obesity)
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

DR R C Agrawal

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

DR R C Agrawal

Senior Surgeon

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

R C Agrawal, MBBS,MS,FICS

Role: PRINCIPAL_INVESTIGATOR

Knee Pain Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arogya Sadan Nursing Home

Bhind, Madhya Pradesh, India

Site Status

Sai Baba Dharmarth Chikitsalaya

Gwalior, Madhya Pradesh, India

Site Status

Parashar Poly Clinic

Gwalior, Madhya Pradesh, India

Site Status

Knee Pain Clinic

Gwalior, Madhya Pradesh, India

Site Status

Lok Hitkari Trust Health Camp

Gwalior, Madhya Pradesh, India

Site Status

Dr. Shukla Surgery Center

Morena, Madhya Pradesh, India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

Related Links

Access external resources that provide additional context or updates about the study.

https://www.orthopaedicscore.com/scorepages/knee_injury_osteopaedic_outcome_score_womac.html

The WOMAC is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4287662/

EuroQol-visual analogue scales - It measure the health status on 20 cms. vertical scale, 0-100, 100 represent best health.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.